K-number	K163144
Device name	gke Steri-Record Steam Mini-Bio-Plus self-contained biological indicator (SCBI)
Applicant	Gke-GmbH
Product code	FRC
Device class	Class II
Decision date	Apr 7, 2017
Decision	Substantially Equivalent
Regulation	880.2800

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Source

View the full FDA submission: accessdata.fda.gov

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gke Steri-Record Steam Mini-Bio-Plus self-contained biological indicator (SCBI)

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